EDC and Risk-based Monitoring

Electronic data capture (EDC) is evolving as a critical element of risk-based monitoring. Traditional monitoring can be seen as a one-size-fits-all approach to site monitoring. Risk-based monitoring, however, is an approach to clinical site monitoring that is more proactive in that it tackles issues with the study based on key performance indicators and assigns resources where they are required most, thus increasing overall efficiency. David Lopez and Richard Garcia at ArisGlobal investigate the increasingly critical role of EDC systems in the execution of clinical trials.